Zyban contains the active ingredient bupropion hydrochloride in an extended-release tablet form. Bupropion, intended as a non-nicotine aid for smoking cessation, is an agent chemically unrelated to other nicotine addiction treatments. It is provided as a 150 mg sustained-release oral tablet with key inactive ingredients like copovidone, cysteine hydrochloride, and hypromellose.

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Do not cut, crush or chew this medication. Take your medication at regular intervals. If you take this medication more than once a day, take your second dose at least 8 hours after you take your first dose. To limit trouble in sleeping, avoid taking this medication at bedtime. Do not take your medication more often than directed. Do not stop taking this medication suddenly except upon the advice of your care team. Stopping this medication too quickly may cause serious side effects. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip the missed dose and take your next tablet at the regular time. There should be at least 8 hours between doses. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Keep container tightly closed. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Increase in blood pressure -Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression -Redness, blistering, peeling, or loosening of the skin, including inside the mouth -Seizures -Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Constipation -Dizziness -Dry mouth -Loss of appetite -Nausea -Tremors or shaking -Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -An eating disorder, such as anorexia or bulimia -Bipolar disorder or psychosis -Diabetes or high blood sugar, treated with medication -Glaucoma -Head injury or brain tumor -Heart disease, previous heart attack, or irregular heart beat -High blood pressure -Kidney disease -Liver disease -Seizures -Suicidal thoughts, plans, or attempt by you or a family member -Tourette syndrome -Weight loss -An unusual or allergic reaction to bupropion, other medications, foods, dyes, or preservatives -Pregnant or trying to become pregnant -Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following: -Linezolid -MAOIs, such as Azilect, Carbex, Eldepryl, Marplan, Nardil, and Parnate -Methylene blue (injected into a vein) -Other medications that contain bupropion, such as Wellbutrin This medication may also interact with the following: -Alcohol -Certain medications for anxiety or sleep -Certain medications for blood pressure, such as metoprolol, propranolol -Certain medications for HIV or AIDS, such as efavirenz, lopinavir, nelfinavir, ritonavir -Certain medications for irregular heartbeat, such as propafenone, flecainide -Certain medications for mental health conditions -Certain medications for Parkinson disease, such as amantadine, levodopa -Certain medications for seizures, such as carbamazepine, phenytoin, phenobarbital -Cimetidine -Clopidogrel -Cyclophosphamide -Digoxin -Furazolidone -Isoniazid -Nicotine -Orphenadrine -Procarbazine -Steroid medications, such as prednisone or cortisone -Stimulant medications for attention disorders, weight loss, or to stay awake -Tamoxifen -Theophylline -Thiotepa -Ticlopidine -Tramadol -Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. This medication should be used together with a patient support program. It is important to participate in a behavioral program, counseling, or other support program that is recommended by your care team. This medication may cause thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression. This medication may cause mood and behavior changes, such as anxiety, nervousness, irritability, hostility, restlessness, excitability, hyperactivity, or trouble sleeping. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you notice any of these symptoms. This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms. Avoid drinks that contain alcohol while taking this medication. Drinking large amounts of alcohol, using sleeping or anxiety medications, or quickly stopping the use of these agents while taking this medication may increase your risk for a seizure. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Do not take this medication close to bedtime. It may prevent you from sleeping. Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe. Do not use nicotine patches or chewing gum without the advice of your care team while taking this medication. You may need to have your blood pressure taken regularly if your doctor recommends that you use both nicotine and this medication together.

What are the most serious risks of this medication?

This medication may increase thoughts of suicide. This may be more common in children, teenagers, and young adults. The risk may increase after first starting the medication and after dose changes. Talk to your care team right away if you have changes in mood and behavior or thoughts of self-harm or suicide.